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Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.

Study Phase:

2

Recruitment Status:

Trial Completed

Study Drug(s):

Pioglitazone

Number of Participants Being Recruited:

20

Single / Multi-Center:

Single Center

STUDY BACKGROUND INFORMATION:

This study examined the role of a drug in reducing inflammation commonly seen in CF lung disease. Increased production of mucus in patients with CF contributes to the increase of bacteria that lead to lung infection and inflammation. Researchers studied whether a drug called pioglitazone could decrease inflammation in cystic fibrosis lung disease. Pioglitazone is already in used clinically to treat other diseases and has a well-established safety profile. Markers of inflammationâ??including levels of bacteria and white blood cellsâ??were measured before and after a 4 week treatment period with pioglitazone in clinically stable CF patients. A total of 20 CF volunteers 28 years or older were expected to enroll in the study.

ELIGIBILITY

Age:

>= 18 Years

FEV1:

>= 40 Percent Predicted

P. aeruginosa status:

Not applicable

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

Twenty CF patients received 4 weeks of once daily treatment with pioglitazone. All subjects completed the study. The only significant change in anti-inflammatory markers was a reduction in the percent of neutrophils in induced sputum (from 82.5% at baseline to 74.4% at end of treatment).

Secondary Efficacy:

Not applicable

Safety:

Serum chemistry values were unchanged, however, the hematology results showed small but significantly significant decreases in RBCs, hematocrit, platelets and eosoinophils. A small but significant decrease in FCV % predicted was observed (-1.95%)Treatment was otherwise, well-tolerated.

The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2008). These data may be preliminary and have not been peer-reviewed.